(36 days)
The Route 92 Medical 070 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
The Route 92 Medical 070 Access System is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical 070 Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
This document describes the Route 92 Medical 070 Access System, a percutaneous catheter intended to facilitate the insertion and guidance of microcatheters in the neurovascular system. The provided text, K203043, is a 510(k) summary from the FDA, detailing the device's substantial equivalence to a predicate device based on non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally "All samples met the pre-determined acceptance criteria" for each test. The actual numerical thresholds for these criteria are not explicitly stated in this document but are implied to be established standards for such medical devices.
| Test | Test Method | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO MEM Elution | The test article is non-cytotoxic. |
| Sensitization | ISO Guinea Pig Maximization Sensitization Test (Normal Saline and Sesame Oil) | The test article did not elicit a sensitization response. |
| Irritation | ISO Intracutaneous Reactivity (Normal Saline and Sesame Oil) | Requirements of the ISO intracutaneous reactivity test have been met for the test article. |
| Acute Systemic Toxicity | ISO Acute Systemic Injection (Normal Saline and Sesame Oil) | Requirements of the ISO acute systemic injection test have been met for the test article. |
| Pyrogen | Material Mediated Pyrogen (Normal Saline) | The test article is non-pyrogenic. |
| Hemocompatibility – Complement Activation | Complement Activation (SC5b-9) | The test article would not be expected to result in adverse effects in vivo. |
| Hemocompatibility – Partial Thromboplastin Time | Partial Thromboplastin Time | The test article is considered to be a non-activator of the intrinsic coagulation pathway. |
| Hemocompatibility – ASTM Hemolysis | ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility – Thromboresistance | Thromboresistance | The test articles have similar thromboresistance characteristics as the control devices. |
| Performance Testing | ||
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications. | PASS (All samples met the pre-determined acceptance criteria) |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | PASS (All samples met the pre-determined acceptance criteria) |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PASS (All samples met the pre-determined acceptance criteria) |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | PASS (All samples met the pre-determined acceptance criteria) |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS (All samples met the pre-determined acceptance criteria) |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS (All samples met the pre-determined acceptance criteria) |
| Liquid Leakage / Static Burst | Tested per ISO 10555-1:2013 Annex C. | PASS (All samples met the pre-determined acceptance criteria) |
| Dynamic Burst | Mechanical integrity was maintained up to the specified pressures. | PASS (All samples met the pre-determined acceptance criteria) |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | PASS (All samples met the pre-determined acceptance criteria) |
| Particulate Recovery | After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP . Particulates were characterized for size ranges ≥10 um, ≥25 um, ≥50 µm, ≥100 µm, ≥200 µm, ≥500 µm and ≥1000 µm. | PASS (All samples met the pre-determined acceptance criteria) |
| Simulated Use Testing | Deliverability and compatibility with accessory devices was evaluated in a neurovascular model. | PASS (All samples met the pre-determined acceptance criteria) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" but does not specify the exact number of samples used for each test set.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) and were conducted by the manufacturer (Route 92 Medical, Inc.) to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated but is implicitly the United States, given the FDA submission. The data is prospective for the purpose of this 510(k) submission, as it was generated specifically to support the clearance of this device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Ground Truth Establishment: For non-clinical performance and biocompatibility testing of a medical device like this catheter, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM, USP) and engineering specifications. It's not based on expert consensus in the same way as, for example, image interpretation.
- Experts: The document does not mention the use of human experts to establish ground truth for these non-clinical tests. The tests themselves provide the "ground truth" against the established quantitative criteria from the standards.
4. Adjudication Method
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or multi-reader reviews involving subjective assessments, especially for diagnostic devices. This is a non-clinical, bench-top testing summary. Therefore, an adjudication method as described is not applicable and was not used. The results are compared directly to predefined quantitative pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a physical medical device (catheter system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. Standalone Performance
- Yes, a standalone performance study was done. All the listed biocompatibility and performance tests are standalone evaluations of the device's physical and biological characteristics without human intervention in the test setup (beyond conducting the test itself). The device itself is not an AI algorithm, so the term "algorithm only" is not directly applicable, but the tests were "device only" performance assessments.
7. Type of Ground Truth Used
- The ground truth used for the non-clinical tests is based on established industry standards and documented engineering specifications/acceptance criteria. These standards include:
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for biocompatibility.
- ISO 10555-1:2013: Intravascular Catheters - Sterile Single-Use Catheters - Part 1: General Requirements for Air and Liquid Leakage / Static Burst.
- USP : Particulate Matter in Injections for particulate recovery.
- Generic acceptance criteria for mechanical properties (Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Dynamic Burst, Hydrophilic Coating Integrity, Dimensional Verification) which would be defined by the manufacturer based on expected performance and comparison to predicate devices, and internal design requirements.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is a physical medical device, not an AI model.
In summary, the K203043 submission demonstrates the substantial equivalence of the Route 92 Medical 070 Access System through comprehensive non-clinical testing. The device met all pre-determined acceptance criteria based on established industry standards and internal specifications, confirming its safety and performance for its intended use.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).